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Tomivosertib

Phase 2

Solid Tumors | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Mar 22, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

Tomivosertib · 1 trial · 1 indication

Phase 2 1
NCT03616834Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor TherapySolid Tumors
COMPLETED39 Analytics
PHASE2COMPLETED
Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects with treatment-emergent AEs (TEAEs) and serious AEs (SAEs)
52 weeks

The incidence of TEAEs and SAEs will be summarized and TEAEs will also be summarized by severity and according to their relationship to Tomivosertib (eFT-508).

Overall Response Rate (ORR) as determined by RECIST 1.1
52 weeks

Defined as the proportion of subjects who achieve a best overall response of complete response (CR) or partial response (PR).

Progression Free Survival (PFS) as determined by RECIST 1.1
52 weeks

Defined as the interval from the start of Tomivosertib (eFT-508) to the occurrence of PD or death from any cause.

Secondary Endpoints

ORR as determined by iRECIST
52 weeks
PFS as determined by iRECIST
52 weeks
Overall survival
52 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tomivosertib (eFT-508)EXPERIMENTALTomivosertib (eFT-508) will be taken at 200 mg twice daily (bid). Subjects will continue their anti-PD-1/anti-PD-L1 therapy, which they had already initiated per standard of care according to the package insert.

Interventions

NameTypeDescription
Tomivosertib (eFT-508)DRUGTomivosertib (eFT-508) is a novel, small-molecule investigational drug being developed by eFFECTOR Therapeutics, as an antitumor therapy that acts by selectively inhibiting mitogen-activated protein kinase (MAPK)-interacting serine/threonine kinase (MNK)1 and MNK 2.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Must provide written informed consent and any authorizations required by local law; * Men or women 18 years of age; * Initiated monotherapy with an anti-PD-1 or anti-PD-L1 agent (avelumab, atezolizumab, durvalumab, nivolumab, or pembrolizumab) in accordance with the package in...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about Tomivosertib

What is Tomivosertib used for?

Tomivosertib is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 2 clinical development. The drug is being evaluated in combination with PD-1/PD-L1 inhibitor therapy for patients with solid tumors.

Who makes Tomivosertib?

Tomivosertib is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The drug is currently in Phase 2 clinical development for the treatment of solid tumors.

What phase is Tomivosertib in?

Tomivosertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of solid tumors, with one completed clinical trial.

What clinical trials is Tomivosertib in?

Tomivosertib has been studied in one clinical trial with the identifier NCT03616834. This Phase 2 trial evaluated Tomivosertib in combination with PD-1/PD-L1 inhibitor therapy for solid tumors. The trial was completed and enrolled 39 participants in the United States.

Is Tomivosertib the same as eFT-508?

Yes, Tomivosertib is also known as eFT-508. In clinical trials, it has been referred to as eFT-508, as seen in the trial title for NCT03616834. The drug is being developed for the treatment of solid tumors.